Peripheral Vascular Diseases
Conditions
Brief summary
Comparison of two kinds of protheses for bridging of the femoropoplitea and/or femorotibiale: PTFE with or without bounded heparin
Detailed description
Comparison of two kinds of protheses for bridging of the femoropoplitea and/or femorotibiale: PTFE with or without bounded heparin. Evaluation of this comparison by clinical systems: ankle-arm index, duplex echo, follow-up of 2 years
Interventions
DEVICEBridging by PTFE with bounded heparin
Bridging by PTFE with bounded heparin
DEVICEBridging by PTFE without bounded heparin
Bridging by PTFE without bounded heparin
Sponsors
JOTEC Company
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with Peripheral Vascular Diseases with complaints of invalidating claudication, rest pain, ucera or gangrene * Patients with damage of the arteria femoralis superficialis or poplitea, longer than 6 cm * Reasonable outflow arteria * Informed consent * Patient able to take part in all follow-up examinations
Exclusion criteria
* Acute ischemia of the leg * Patients with a ipsilateral inflow stenosis of more than 70% which can not be corrected before or during the surgery * \< 18 years * Pregnancy * Recent heart attack (\< 1 month) * Life expectancy less than 12 months * Known allergy to heparin * Known contrast allergy * Known bleeding or coagulation disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary patency after 2 years | after 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Secondary patency | after 2 years |
| Limb salvage | after 2 years |
| Mortality | after 2 years |
| Re-intervention | after 2 years |
Countries
Belgium
Outcome results
None listed